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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, image processing, radiological
510(k) Number K103458
Device Name VIEWPOINT 6
Original Applicant
GE HEALTHCARE
3000 north grandview blvd
#w450
waukesha,  WI  53188
Original Contact nicole landreville
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received11/23/2010
Decision Date 03/04/2011
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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